Kornimate/medical-research-clean huggingface dataset:
raltitrexed and paclitaxel for gastric or gastroesophageal junction adenocarcinoma

Conditions: Gastric Cancer; Gastroesophageal Junction Adenocarcinoma

Summary: this is a single-arm clinical trial.the purpose of this study is to evaluate the efficacy and safety of raltitrexed and paclitaxel as second-line chemotherapy for patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma .the primary endpoint of this study is objective response rate.the secondary endpoint of this study is safety,progression-free survival and overall survival.

raltitrexed is an antifolate thymidylate synthase inhibitor that has shown efficacy and good safety profile in the treatment of colorectal cancer. to our knowledge, there has been no study published with the raltitrexed and paclitaxel regimen as second-line chemotherapy for patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.the aim of our study was to evaluate the efficacy, safety and survival of this regimen in patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma; * patients failed first-line chemotherapy containing fluoropyrimidines and platinums; * ecog (eastern cooperative oncology group)performance status 0-1; * at least 1 measurable lesion should be present（recist1.1） * available organ function: neutrophils\>2g/l, hemoglobin\>9g/l, blood platelet \>100g/l; alanine aminotransferase(alt） and aspartate aminotransferase(ast)\<1.5 uln(upper limit of normal); total bilirubin(tbil)\<1.0 uln; cr \<1.0uln * signed informed consent. * life expectancy ≥3 months; exclusion criteria: * previous treatment with raltitrexed or paclitaxel; * known history of allergic reaction to raltitrexed or paclitaxel; * known brain metastases; * pregnant or breast feeding women; * severe diarrhea,intestinal obstruction; * other co-existing malignancies or malignancies diagnosed within the last 5 years(except cured cutaneum carcinoma or carcinoma in situs of cervix); * previous myocardial infarction, unstable angina, stroke ,or uncontrollable arrhythmia; * kown hiv infecton.

Keywords: raltitrexed paclitaxel chemotherapy gastric cancer gastroesophageal junction adenocarcinoma
hvni for successful weaning in respiratory failure

Conditions: Respiratory Failure; Weaning Failure

Summary: the goal of this randomized active-controlled study is to investigate the role of high velocity nasal insufflation (hvni) in the immediate post-extubation period and compare it with non-invasive positive pressure ventilation (nippv) as regards to weaning success rate. the study will recruit those who have been on invasive mechanical ventilation for at least 3 days and with a high risk of weaning failure.

this is a single center prospective randomized controlled open label trial of high velocity nasal insufflation (hvni) in the immediate post-extubation period versus noninvasive positive pressure ventilation (nippv). after at least 72 hours from intubation, for respiratoy failure, those who are considered to be eligible for weaning from mechanical ventilation based on the weaning protocol but are at high risk for extubation failure will be randomized to either hvni or nippv. data on the respiratory and cardiovascular status will be continuously monitored and recorded thereafter. the primary outcome measure will be failure of either arm within 72 hours of initiation, leading to reintubation (or crossover only from a failed hvni allocation to niv based on clinical judgement to avoid reintubation in selected cases). secondary outcomes to be investigated include: 1) failure of hvni or nippv after 72 hours from initiation, 2) hospital mortality, 3) length of icu stay, 4) length of hospital stay, 5) incidence of ventilator associated pneumonia, 6) patient tolerance and comfort, and 7) icu readmission or mortality at 28-days post hospital discharge.

Eligibility criteria:
inclusion criteria: high risk of extubation failure (one or more of the following): 1. age \>65 years old 2. bmi \>30 3. apache ii score at extubation \>12 4. ≥2 comorbidities 5. endotracheal intubation \> 7 days 6. ≥1 failed attempts at disconnection from mechanical ventilation 7. chronic lung disease e.g., copd, ohs, etc. 8. underlying left ventricular dysfunction 9. non-minimal airway secretions exclusion criteria: 1. non-respiratory failure patients 2. patients judged to need a tracheostomy (poor airway reflexes or copious secretions) 3. patients who cannot tolerate an oral or nasal interface (facial trauma or perforated nasal septum) 4. patients with increased risk of aspiration, agitation, or uncooperativeness 5. end stage disease with life expectancy less than 6 months

Keywords: hvni non-invasive ventilation weaning failure extubation respiratory failure
evaluation of deaf men's knowledge about sexual health

Conditions: Deafness; Sexual Satisfaction; Sexually Transmitted Diseases; Sexual Violence; Educational Problems

Summary: evaluation of deaf men's knowledge about sexual health in nancy, france. the study consists of interviews with voluntary deaf men from nancy, france, in order to assess their knowledge about sexual health, and determine if there is a lack of sexual health awareness. if there is indeed a lack of information about sexual health, the study aims at finding ways of improving the situation, and see how the deaf men would like to have this information delivered to them.

evaluation of deaf men's knowledge about sexual health in nancy, france. the study consists of interviews with voluntary deaf men from nancy, france. the goal is to assess their knowledge about sexual health, and determine if there is a lack of sexual health awareness. if there is indeed a lack of information about sexual health, the study aims at finding ways of improving the situation, and see how the deaf men would like to have sexual health information delivered to them. patients from nancy's regional deaf healthcare service (urassm) will be contacted and volunteers adult deaf men, using sign language as their main langage, will be recruited into the study. the interviews will consist of a series of open questions aiming to evaluate the volunteers knowledge about sexual health, and evaluate their expectations about how sexual health care for deaf men should be dealt with. a professional french sign language translator will be present during the interviews, and all the questions and answers will be delivered using french sign language.

Eligibility criteria:
inclusion criteria: * deaf * over 18 * using french sign language * whithout curatorship or tutelage exclusion criteria: * female * under 18 * non deaf

Keywords: deafness sexual health sexually transmitted diseases sexual violence sexual health awareness
interest of high flow nasal cannula (hfnc) versus non invasive ventilation during the initial management of severe bronchiolitis in infants

Conditions: Bronchiolitis

Summary: 1. the purpose of the study is to evaluate prospectively the clinical benefits of high flow nasal canula (hfnc: 2l/kg/min) versus nasal cpap( continuous positive airway pressure) (n-cpap: 7 cmh2o) in the initial management of bronchiolitis in infants. 2. design: non-inferiority study, prospective, controlled, randomized, multi-center. 3. design: infants less than 6 month admitted in pediatric intensive care unit for respiratory distress (mwcas \>3) secondary to bronchiolitis but not requiring mechanical ventilation will be randomized in two groups: "n-cpap"(nasal continuous positive airway pressure) or "hfnc" during 24 hours. 4. conditions of measurements: primary endpoint: proportion of failure in both arms during the first 24 hours. failure criteria: a raise of the clinical score for respiratory distress (mwcas) (1 point) or respiratory rate (10/min /h0 and above 60/min) or discomfort (edin) (1point /h0 and above 4) or apnea. secondary outcomes: assessment at h1, h12, h24 of mwcas, respiratory and heart rate, edin score, skin lesions, fio2 (fraction of inspired oxygen ) required to achieve an oxygen saturation between 94 and 97%, transcutaneous pco2 (carbon dioxide partial pressure) (correlated to an initial gas analysis), report spo2 / fio2 5. statistic: intention to treat analysis. expected number of patients: 71 per arm: 142 children. 6. study schedule: october 2014-april 2016


Eligibility criteria:
inclusion criteria: * age\<6months * bronchiolitis * mwcas \> or=3 * hospitalisation in pediatric intensive care unit * signed consent form (2 parents) exclusion criteria: * intubated patient * neurological or cardiac disease
a post-marketing clinical study of aricept in patients with dementia with lewy bodies (dlb)

Conditions: Dementia, Lewy Body; Lewy Body Disease

Summary: the purpose of this study is to confirm the efficacy of aricept in patients with dementia with lewy bodies (dlb).


Eligibility criteria:
inclusion criteria 1. patients diagnosed with probable dlb according to the diagnostic criteria for dlb 2. patients having caregivers throughout the study who submit written consent to cooperate with this study, can routinely stay with patients at least 3 days a week (at least 4 hours a day), provide patients' information necessary for this study, assist treatment compliance, and escort the patients on required visits to study institution 3. clinical dementia rating (cdr) score is greater than or equal to 0.5 4. mini-mental state examination (mmse) score is greater than or equal to 10 and less than or equal to 26 exclusion criteria 1. patients diagnosed with parkinson's disease with dementia (pdd) 2. patients who have received anti-dementia drug therapy within 12 weeks before the start of the observation period 3. patients with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, or a history of brain surgery causing unrecovered deficiency 4. patients with severe extrapyramidal disorders (hoehn and yahr staging score is greater than or equal to iv) 5. patients whose systolic blood pressure is less than 90 mmhg or pulse rate is less than 50 beats/minute at screening test

Keywords: dlb dementia with lewy bodies lewy body disease dementia e2020 donepezil aricept
dementia patient's behavior evaluation using noninvasive ambient sensor

Conditions: Mild Cognitive Impairment, Dementia

Summary: this study is an observational study that uses daily activity and environmental sensing techniques to establish behavioral models of early dementia patients and cognitive healthy function to assess their daily behavior and determine their activities. specifically, the team will collect information on a number of wireless sensors for dementia, mild cognitive impairment and healthy elderly residents, and use special mathematical models to establish the behavior of the two groups of subjects model. the model will be developed a reliable algorithm to assess health risk of the subjects.

with the help of intelligent home environment and pervasive computing, it is possible to bring information about the behavior of the patients to the caregivers and their relatives. in this study, non-invasive wireless sensors such as infrared motion sensor the switch sensor will be built in the home of the subjects. the wireless sensor data collected by the input to the team's "activity identification system" in order to assess the mathematical model of the subjects "capacity" and immediate judgment of their activities. in the identification of activities can be divided into two categories of behavior, risk behavior (harmful to the subjects) and protective behavior (beneficial to the subjects), real-time activity detection, can avoid dangerous behavior, such as water and gas off, roaming , repetitive behavior (over-eating), forgetting to eat and day-night reversal (sleep disturbance), etc., the protection of behavior can be observed through a long time to help patients conduct beneficial behavior, such as regular quantitative diet.

Eligibility criteria:
inclusion criteria: * can communicate in mandarin or taiwanese. * consciousness is clear. * can do the daily activity by their own. exclusion criteria: * have a serious cardiopulmonary disease or physical activity is limited to those unable to carry out daily activities. * consciousness is not clear. * difficult communication, such as: aphasia patients, the use of respirator patients. * suffering from serious mental illness that can not match. * adopt absolute isolation, such as: open tuberculosis patients. * hearing or severe visual impairment that can not match. * can not exercise their consent.

Keywords: healthcare quality
activity levels in bone marrow transplant patients

Conditions: Bone Marrow Transplant

Summary: participants in this study will be receiving a bone marrow transplant. this study is designed to evaluate correlations between activity levels and length of stay, quality of life, and hand grip strength.

participants in this study will be receiving a bone marrow transplant. participants will be given actigraphs to wear around their waists starting 3 weeks prior to bone marrow transplants until they are discharged from the hospital. participants will be asked to complete quality of life questionnaires and hand grip tests at three separate time points during their hospitalizations. all data gathered from these activities will be compared with patients' activity levels gathered from the actigraphs both before and during the hospitalization. this study is designed to determine the relationship between activity levels and length of stay, quality of life, and hand grip strength.

Eligibility criteria:
patients who will be receiving a bone marrow transplant are eligible for this study

Keywords: leukemia multiple myeloma myelodysplastic syndrome stem cell transplant
ultrasound and mri measurement of quadriceps femoris muscle in critically ill children

Conditions: Quadriceps Femoris Measurement as a Surrogate of Muscle Mass Assessment in Critically Ill Children

Summary: a vast majority of children admitted to paediatric intensive care (picu) present with faltering growth during their admission. muscle mass loss is an early, intense and frequent phenomenon in this setting, which is associated with impaired outcomes. recent international guidelines recommend monitoring both nutritional status and muscle mass throughout hospital stay. recent studies have used quadriceps femoris (qf) measurements as a surrogate for lean mass assessment, and monitored them with bedside ultrasound (qf thickness and qf cross sectional area). however, ultrasound cross sectional area inter-operator reproducibility has not been validated so far, and none of these ultrasound measurements has been validated against their gold standard i.e. magnetic resonance imaging measurements. this validation process should be conducted to allow interpreting ultrasound muscle measurements, prior to the implementation of ultrasound measurments into clinical practice. we hypothesise that ultrasound measurements of qf thickness and cross sectional area are reliable compared to the magnetic resonance imaging gold standard, and that qf cross sectional area has a reliable inter-operator reproducibility.


Eligibility criteria:
inclusion criteria: * critically ill children from 0 to 17 years old * magnetic resonance imaging planned for any medical reason * sedated child for any medical reason * absence of parental/patient refusal to participate to the study exclusion criteria: * congenital neuromuscular disease * no possible access to the thigh (e.g. dressing, drains, gypsum) * anatomical anomaly of the limb, that would compromise localizing thigh landmarks (patella, groin) * inability to obtain limb rest and/or thigh muscle decontraction * risk induced by mobilization of the patient for ultrasound or magnetic resonance imaging purpose * absence of social insurance

Keywords: ultrasound; magnetic resonance imaging; quadriceps femoris, critically ill children
temporomandibular joint dysfunction in patients with traumatic brain injury

Conditions: Temporomandibular Dysfunction

Summary: trauma, neurological disorders and psychological problems, which are the etiological factors of temporomandibular joint dysfunction, can be seen in patients with traumatic brain injury. the aim of this study is to investigate temporomandibular joint dysfunction in patients with traumatic brain injury. participants (traumatic brain injury patients and healthy volunteers) will be evaluated once for temporomandibular joint dysfunction.

temporomandibular joint range of motion, fonseca questionnaire, facial asymmetry, and massater and temporal pain threshold will be evaluated by measuring both tbi patients and healthy individuals. in addition, post-injury dietary intake and dominant chewing side will be questioned in tbi patients. temporomandibular movements will be measured with a disposable cardboard ruler. exclusion criteria; communication and cooperation problems, congenital or systemic disease affecting the head and neck region, being treated for tmed and having a history of orthognathic surgery.

Eligibility criteria:
inclusion criteria: clinical diagnosis of traumatic brain injury not receiving treatment for temporomandibular joint dysfunction exclusion criteria: communication and cooperation problems, congenital or systemic disease affecting the head and neck region, being treated for tmed and having a history of orthognathic surgery.

Keywords: temporomandibular dysfunction, traumatic brain injury headache
adherence to lifestyle changes for age-related macular degeneration

Conditions: Age-Related Macular Degeneration

Summary: the amd-life study investigates which strategies (personalized risk-profiling including genetic testing and/or coaching) motivate amd patients to change their lifestyle.

age-related macular degeneration is a frequent eye disease in the elderly affecting the center of retina, i.e., the macula. despite current treatments for the wet form of this disease, it is still the most frequent cause of blindness in the western world. the disease is the result of the interplay between genetic and environmental factors such as smoking, unhealthy diet, and lack of physical activity. the current clinical recommendations are aimed towards these lifestyle factors: a healthy diet, no smoking, regular physical exercise, and use of antioxidant supplementation. although assumed to be low by clinicians as they feel patients find it difficult to actually alter their lifestyle, the adherence and feasibility to these recommendations in clinical ophthalmology practice is unclear. individualizing the patients' risk of blindness and lifestyle changes, as well as coaching may positively influence adherence strategies. this pilot study aims to gain knowledge and experience in a relatively small study comparing adherence to these strategies through a healthier lifestyle. additionally, the trial investigates blood and gut microbiome biomarkers: which molecules in blood directly relate to the supplemented nutrients as well as those related to the pathogenesis of amd, and which biomarkers in blood and eye best correlate with supplement intake and lifestyle.

Eligibility criteria:
inclusion criteria: * early/intermediate amd or unilateral late amd with minimal vision 0.8 exclusion criteria: * participation in other intervention studies for amd * living in retirement homes (difficulty in implementation of diet) * diagnosis of dementia (because of unreliable dietary recall) * persons with macular pathology other than amd hindering appropriate grading of the macula * persons who are illiterate and have no independent trusted person with them to explain the informed consent form. * persons diagnosed with liver and kidney insufficiency.

Keywords: age-related macular degeneration lifestyle lifestyle change genetic testing personalized risk-profiling gut microbiome coaching
reduced dose of cyclophosphamide combined with standard immunosuppressive therapy to treat severe aplastic anemia

Conditions: Severe Aplastic Anemia; Cyclophosphamide Reduced-dose; Immunosuppressive Therapy

Summary: this is a prospective, single-center, single-arm, phase 2 study. this study aims to evaluate the efficacy and safety of anti-lymphocyte globulin plus herombopag in combination with the reduced dose of cyclophosphamide (hypo-cash) for severe aplastic anemia.


Eligibility criteria:
inclusion criteria: * subject has a diagnosis of naïve severe or very severe aplastic anemia * male or female age ≥ 12 years * unwilling or unable to receive allogeneic hematopoietic stem cell transplantation. * ecog performance status ≤2 * willing and able to comply with the requirements for this study and written informed consent. exclusion criteria: * previously received immunosuppressive therapy \> 4 weeks * previously treated with tpo-ra \> 4 weeks * have an allergy or intolerance to anti-lymphocyte globulin, cyclosporine, herombopag or cyclophosphamide. * uncontrolled fungal, bacterial, or viral infection. hepatitis-associated aplastic anemia is allowed; hepatitis b or c infection is permitted unless it causes severe liver failure. * tested positive for hiv or syphilis * presence of severe liver, kidney, or heart failure, or other life-threatening comorbidities. * history of radiotherapy and chemotherapy for malignant solid tumors in recent 5 years * combined with other serious disorders * pregnant or breast-feeding patients * patients considered to be ineligible for the study by the investigator for reasons other than the above.
retrospective analysis to describe patient profiles, current treatment patterns and economic burden for asthma patients in uae. a descriptive analysis of the asthma patient population in the emirate of dubai with respect to healthcare resource utilization, costs, and asthma-related treatment pattern

Conditions: Asthma

Summary: this retrospective cohort study with an overall objective of to perform a descriptive analysis of the asthma patient population in the emirate of dubai with respect to healthcare resource utilization, costs, and asthma-related treatment patterns and outcome.


Eligibility criteria:
inclusion criteria: * minimum two claims with asthma diagnosis, 30 days apart, during the identification period * minimum 12 months of baseline period * age ≥ 18 years on the index date * continuous enrolment during the baseline period and at least 180 days of follow-up period; enrolment will be defined based on at least one activity during each 90-day period from the index date exclusion criteria: • diagnosis of copd during the baseline period. diagnosis of copd will be defined as ≥1 medical claim with an icd-10 diagnosis in any position